Ex Parte Wainwright et al

Patent Trial and Appeal BoardNov 20, 2018

13875969 (P.T.A.B. Nov. 20, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/875,969 05/02/2013 51414 7590 11/23/2018 GOODWIN PROCTER LLP PATENT ADMINISTRATOR 100 Northern A venue BOSTON, MA 02210 UNITED ST A TES OF AMERICA FIRST NAMED INVENTOR Norman R. Wainwright UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. CHR-020 1069 EXAMINER MARTIN, PAUL C ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 11/23/2018 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): PA TENTBOS@GOODWINPROCTER.COM PSOUSA-ATWOOD@GOODWINPROCTER.COM GLENN .WILLIAMS@GOODWINPROCTER.COM PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte NORMAN R. WAINWRIGHT, BALA S. MANIAN, ERIC STIMPSON, BRIAN J. KOLONIA, and ROBERT K. KOLONIA Appeal2017-002565 Application 13/875,969 Technology Center 1600 Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and JOHN G. NEW, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. Â§ 134(a), Appellants 1 seek review of Examiner's rejections of claims directed to a cell capture system. We have jurisdiction under 35 U.S.C. Â§ 6(b ). For the reasons set forth below, we reverse. 1 The Appeal Brief ("Appeal Br.") lists Charles River Laboratories, Inc. and ReaMetrix Inc., the assignee of record, as the real party in interest. Appeal Br. 2. Appeal2017-002565 Application 13/875,969 STATEMENT OF THE CASE Claims 1-3, 5-11, and 13-15 are on appeal, and can be found in the Claims Appendix2 of the Appeal Brief. Claim 1, the sole independent claim, is representative of the claims on appeal, and reads as follows: 1. A cell capture system comprising: (a) a fluid permeable, planar membrane comprising an exposed first surface and a second opposing surface, at least a portion of the first surface is adapted to retain cells thereon, the portion: (i) defining a plurality of pores having an average diameter less than about 1 Âµm so as to permit fluid to traverse the portion of the membrane while retaining cells thereon; (ii) being substantially non-autofluorescent when exposed to light having a wavelength in a range from about 350 nm to about 1000 nm; and (iii) having a flatness tolerance ofup to about 100 Âµm when a fluid sample has passed through the membrane; (b) a fluid permeable support member adjacent and supporting at least a portion of the second opposing surface of the membrane, the fluid permeable support member comprising an upper surface that contacts the second opposing surface of the membrane and has a flatness tolerance of up to about 100 Âµm so as to maintain the flatness tolerance of the portion of the membrane when the fluid sample has passed through the membrane; and ( c) an optional register associated with the membrane. Claims Appendix 1 (formatting added for clarity). 2 This opinion references the Appeal Brief filed April 24, 2016 ("Appeal Br."), response to notification of non-compliant Appeal Brief filed August 24, 2016 ("Claims Appendix"), and Reply Brief filed December 2, 2016 ("Reply Br."). 2 Appeal2017-002565 Application 13/875,969 Appellants request review of the following rejections: I. Claims 1-3, 5, 8-11, and 13 under pre-AIA 35 U.S.C. Â§ 103(a) as unpatentable over Chemunex3 as evidenced by Sterlitech. 4 II. Claims 1-3, 5-11, and 13-15 under pre-AIA 35 U.S.C. Â§ 103(a) as unpatentable over Chemunex as evidenced by Sterlitech and further in view of Clark. 5 Since both of these rejections rely upon the teaching of Chemunex and Sterlitech regarding the cell capture system and more specifically the fluid permeable membrane and membrane support member, the same issue is dispositive for both of these rejections, so we will consider the rejections together. Examiner finds "that Chemunex teaches a cell capture system comprising an open cylindrical portion adapted to mate with a base comprising a fluid permeable, planar membrane," specifically, a polyester track-etched membrane. Ans. 12. Examiner acknowledges that Chemunex reference is silent with regard to the membrane having a flatness tolerance of up to about 100 Âµm when in use, [Examiner finds that] this appears to be either; an inherent characteristic in the reference as the characteristic properties of the porous membrane cell capture system of the instant application and the porous polyester membrane cell capture 3 AES YYY Chemunex: The Rapid Microbiology Company, ABRASP Meeting Sao Paulo, October 20, 2011 ("Chemunex"). This document is not paginated, therefore page numbers refer to the document as if it were consecutively paginated beginning on the first page. 4 PETE (Polyester) Membranes, http://www. ster litech. com/ filters/ membrane-disc-filters/po 1 yester-pete- membranes .html (last accessed April 23, 2014) ("Sterlitech"). 5 Clark et al., US 5,603,900, issued Feb. 18, 1997 ("Clark"). 3 Appeal2017-002565 Application 13/875,969 system comprising a track-etch polyester porous membrane of the prior art appear to be identical. Ans. 13 (citing Spec. ,r 77). Examiner, however, is not persuaded by the submitted Declaration because "statements appear to be wholly unsupported by any evidence on the record and appear to be directed to criticality of the flatness tolerance of the membrane and that of the prior art when in use" noting that the present claims are directed to a cell capture system and not a method of using the system. Ans. 13, see id. at 18. Appellants contend that "[ n ]either Chemunex nor Sterlitech include any mention of a flatness tolerance of a planar membrane or a support member." Appeal Br. 8. "[T]he flatness tolerance of our membrane in our claimed cell capture system is achieved at least in part by using a fluid permeable support member with a membrane contacting surface having a flatness tolerance ofup to about 100 Âµm." Id. at 11 (citing Manian Decl. 6 ,r 15). "Appellants submit that the requisite flatness tolerance of the planar membrane in the claimed cell capture system is not inherent in Chemunex, as evidenced by Sterlitech." Id. at 15; see Reply Br. 5. Appellants also contend that Examiner improperly dismisses Dr. Manian's testimony. Reply Br. 5. In arriving at the conclusion that the prior art renders the present claims obvious Examiner relies on inherency of the polyester track-etched membrane described in Chemunex. See Ans. 2-3, 8. Chemunex protocol has three steps: filtration, labeling, and laser scanning. Chemunex 8. Specifically, Chemunex teaches using a generic 0.4 Âµm polyester track- 6 Declaration of Dr. Bala S. Manian under 37 C.F.R. Â§ 1.132, signed April 29, 2015. 4 Appeal2017-002565 Application 13/875,969 etched membrane for use in their standard filtration units. Id. We note, however, that other than citing the thickness of the membrane the reference is silent with respect to the brand of polyester membrane used. Examiner relies on Sterlitech PETE membrane to establish that the membrane disclosed in Chemunex possess the recited flatness feature. See Ans. 3 ("Sterlitech teaches that a polyester membrane with a pore size of 0.4 Âµm (as taught by Chemunex) has a thickness of 9 Âµm"). The Specification teaches that suitable membranes include: nylon, nitrocellulose, polycarbonate, polyacrylic acid, poly(methyl methacrylate) (PMMA), polyester, polysulfone, polytetrafluoroethylene (PTFE), or polyethylene membrane impregnated with carbon black or sputtered with an inert metal such as but not limited to gold, tin or titanium. Membranes that have the appropriate pore size which are substantially nonautofluorescent include, for example, Isopore membranes (Merck Millipore), Nucleopore TrackEtch membranes (Whatman), ipBLACK Track Etched Membranes ( distributed by AR Brown, Pittsburgh, PA), and Polycarbonate (PCTE) membrane (Sterlitech). Spec. 77. We note that the Specification generically recites polyester as a suitable membrane. The Specification, however, does not list the PETE Sterlitech membrane as a membrane specifically meeting the pore size and nonautofluorescent character desirable for use in the claimed system. See Id. The Specification also does not use the PETE Sterlitech membrane in any experiments. Thus, it is not clear on what basis Examiner concludes that the PETE Sterlitech membrane relied on in the rejection meets the requisite flatness requirement. Appellants contend that achieving the flatness tolerance in the fluid permeable membrane not only requires the use of particular type of membrane but also requires the use of a requisite fluid permeable support 5 Appeal2017-002565 Application 13/875,969 that also meets the particular flatness requirement. See Appeal Br. 11 ( citing Manian Deel. ,r 15); Spec. ,r 70 ("preferable to use a support system that maintains the membrane and any captured cells in a substantially planar orientation and within a suitably tight flatness tolerance to permit reliable detection,"), id. ,r 86 ("solid substantially planar element that keeps membrane 202 in a substantially planar configuration, for example, when the membrane is wetted"). Chemunex is silent with respect to the structure that supports the capture membrane. See Chemunex 9. "Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient." In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (internal quotation marks omitted). We note that Chemunex shows a membrane support structure, but find that the reference is silent with respect to describing any properties of that support structure. Thus, the evidence of record does not support Examiner's position that the combination of references renders the claims obvious based on inherency because Examiner has not established that Chemunex would necessarily have a fluid permeable support member that has the requisite flatness tolerance. Finally, Examiner finds that the Declarant's statement is "wholly unsupported by any evidence" and is directed to the use of the membrane and thereby is not directed to discussing the structural properties of the system. Ans. 13. The Manian Declaration explains: the flatness tolerance of our membrane in our claimed cell capture system is achieved at least in part by using a fluid permeable support member with a membrane contacting surface 6 Appeal2017-002565 Application 13/875,969 having a flatness tolerance ofup to about 100 Âµm .... When we used a membrane in a cell capture system that did not meet the flatness tolerance requirement of up to about 100 Âµm, i.e., withinÂ± 50 Âµm, it was not possible to reliably scan the cells captured on the membrane. Manian Deel. ,r 15. We understand that the Declaration does not describe what particular membrane was assayed, but find that the Declaration sufficiently supports the position that not all membranes are equally suitable in the system. Examiner's response appears to dismiss this evidence because the evidence "appear[s] to be directed to criticality of the flatness tolerance of the membrane and that of the prior art when in use." Ans. 13. As the court stated in Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1549 Fed. Cir. 1983): It is inappropriate and injudicious to disregard any admissible evidence in any judicial proceeding. Hence all relevant evidence on the obviousness issue must be considered before a conclusion is reached. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530 (Fed. Cir. 1983). Here, we find that the Manian Declaration sufficiently establishes that not all membranes are sufficiently flat to reliably scan the cells captured on the membrane. Manian Deel. ,r 15 ("[T]he flatness tolerance of our membrane in our ... capture system is achieved at least in part by using a fluid permeable support member with a membrane contacting surface having a flatness tolerance ofup to about 100 Âµm"). We understand that it would be desirable to have more information with respect to the specific membrane and cell capture system relied on in the Declaration, but find that this is not necessary to establish that not all membranes are equally suitable for the recited purpose. 7 Appeal2017-002565 Application 13/875,969 SUMMARY The evidence of record does not support Examiner's conclusion that the Chemunex and Sterlitech together teach a fluid permeable planar membrane and a fluid permeable support member having the claimed flatness tolerance. Accordingly, we reverse the rejections relying on Chemunex and Sterlitech. REVERSED 8